Standard Treatment Response for Rectal Cancer

Recruiting at 5 trial locations

Overseen By Andrea Cercek, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Fluoropyrimidines

Must not be taking: Blood thinners

Disqualifiers: Prior malignancy, Prior pelvic radiation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on blood thinners, you may not be eligible to participate.

What data supports the effectiveness of the treatment Endoscopy, Endoscopic examination, Gastrointestinal endoscopy for rectal cancer?

Research shows that endoscopic examination is important in identifying a complete response in rectal cancer patients after chemoradiotherapy, which can help determine if a nonoperative approach is suitable. ^{1 2 3 4 5}

Is endoscopy generally safe for humans?

Endoscopy is generally safe, but it can have some risks. Serious side effects, like bleeding and tears in the colon, happen in about 2.8 out of every 1000 procedures, especially when removing growths (polypectomy). ^{6 7 8 9 10}

How does the treatment for rectal cancer differ from other treatments?

This treatment for rectal cancer is unique because it focuses on a 'watch-and-wait' approach after chemoradiotherapy, using endoscopy to identify a complete response, which may allow some patients to avoid surgery if their cancer responds well. ^{1 2 3 5 11}

What is the purpose of this trial?

The purpose of the study is to learn more about how the body responds to standard treatment (chemoradiation and chemotherapy). The study will use the results of testing down on participants' blook, tissue, and scans to learn more about how people with rectal cancer respond to chemoradiation and chemotherapy treatment and if it is useful for predicting whether a person's cancer get better, gets worse, or stats the same after treatment.

Research Team

Paul B. Romesser

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for individuals with rectal cancer, specifically adenocarcinoma. Participants will undergo standard treatments before potential surgery. The study aims to include those who can provide blood and tissue samples, as well as undergo scans.

Inclusion Criteria

My rectal cancer is confirmed and does not have specific genetic features.

I am starting standard chemotherapy for my condition.

I am a woman who can become pregnant, not currently pregnant, and agree to use birth control during the study.

Exclusion Criteria

I am on blood thinners that prevent me from having certain cancer tissue tests.

I am not using any form of birth control.

I have had radiation therapy to my pelvis or seed implantation in my prostate.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemoradiation

Participants receive standard chemoradiation therapy as part of neoadjuvant treatment

5-6 weeks

Chemotherapy

Participants receive standard chemotherapy following chemoradiation

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

Treatment Details

Interventions

• Endoscopy

Trial Overview The trial is studying how people with rectal cancer respond to the usual treatment combo of chemoradiation and chemotherapy. It involves monitoring changes in the body through blood tests, tissue analysis, and imaging scans.

Participant Groups

Group I: Participants with Rectal Cancer Experimental Treatment 1 Intervention

Participants will be diagnosed with rectal cancer and will be undergoing standard-of-care neoadjuvant therapy.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

Endoscopy can effectively identify over 70% of patients with a clinical complete response (CR) after neoadjuvant treatment for rectal cancer, with a median time to endoscopy of about 9 weeks.

The presence of a flat scar during endoscopy is the most predictive feature of CR, with a positive predictive value of 70%-80%, suggesting that specific endoscopic findings can help determine which patients may benefit from a watch-and-wait approach for organ preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive Value of Endoscopic Features for a Complete Response After Chemoradiotherapy for Rectal Cancer. van der Sande, ME., Maas, M., Melenhorst, J., et al.[2021]

Endoscopic evaluation of complete response (E-CR) after preoperative chemoradiotherapy in rectal cancer showed a high accuracy of 91.7%, indicating it is a reliable method for assessing tumor response.

The study found that E-CR criteria led to all cases of clinical complete response (ycCR) being confirmed as pathological complete response, suggesting that this evaluation method can effectively guide treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic evaluation of clinical response after preoperative chemoradiotherapy for lower rectal cancer: the significance of endoscopic complete response. Ogura, A., Chino, A., Konishi, T., et al.[2018]

In a study of 61 patients with high-risk rectal cancer, adding narrow-band imaging to conventional chromoendoscopy improved the inter-rater agreement between expert and trainee endoscopists, indicating better consistency in diagnosing clinical complete response after neoadjuvant therapy.

While the overall diagnostic accuracy for predicting pathologic complete response showed only a modest improvement (from 70.5% to 75.4%), narrow-band imaging did enhance sensitivity and negative predictive value, suggesting it may be a useful tool for standardizing assessments in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding Narrow-Band Imaging to Chromoendoscopy for the Evaluation of Tumor Response to Neoadjuvant Therapy in Rectal Cancer. Ishioka, M., Chino, A., Ide, D., et al.[2021]

Surgeons showed significant variation in assessing tumor response in rectal cancer patients after neoadjuvant treatment, but they were generally consistent in identifying complete responses, achieving an accuracy of 82%.

The study highlights the importance of endoscopic examination in determining treatment response, suggesting that while there is variability among surgeons, the interpretation of endoscopic features for grading tumor response is reliable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic Feature and Response Reproducibility in Tumor Assessment after Neoadjuvant Therapy for Rectal Adenocarcinoma. Felder, SI., Patil, S., Kennedy, E., et al.[2022]

Recent studies indicate that some rectal cancer patients who show a complete clinical response after neoadjuvant therapy may be effectively managed without surgery, suggesting a shift in treatment strategies.

This review highlights the importance of follow-up endoscopy in assessing patient responses to chemoradiotherapy, which can guide decisions on nonoperative management for those with significant improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of complete response after chemoradiation in rectal cancer. Weiser, MR., Beets-Tan, R., Beets, G.[2013]

A study of over 2.3 million outpatient colonoscopies revealed that more complex polypectomy techniques, such as snares and hot forceps, significantly increase the risk of serious gastrointestinal adverse events like colonic perforations and GI bleeding compared to simple colonoscopy.

Patients treated by low-volume endoscopists and those undergoing procedures in ambulatory surgery centers also faced higher risks of complications, suggesting that opting for simpler techniques or high-volume specialists could help reduce these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of polypectomy techniques, endoscopist volume, and facility type with colonoscopy complications. Chukmaitov, A., Bradley, CJ., Dahman, B., et al.[2023]

A new grading system for the complexity of endoscopic procedures was established through consensus voting among gastroenterologists in the US, Canada, and Britain, categorizing procedures from level 1 (easiest) to level 4 (most difficult).

This consensus list aims to enhance the understanding of procedure complexity, complementing existing lexicons for adverse events and risk factors, although it is based more on expert opinion than empirical evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Grading the complexity of endoscopic procedures: results of an ASGE working party. Cotton, PB., Eisen, G., Romagnuolo, J., et al.[2022]

In a study of 226 patients who underwent endoscopic resection for superficial duodenal epithelial tumors, the surgical conversion rate due to adverse events was 8.0%, with delayed perforation presenting the highest risk for conversion at 50%.

Significant risk factors for surgical conversion included involvement of the major papilla and delayed perforation, highlighting the need for careful monitoring and prevention strategies within the first three days post-procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical course and management of adverse events after endoscopic resection of superficial duodenal epithelial tumors: Multicenter retrospective study. Dohi, O., Kato, M., Takeuchi, Y., et al.[2023]

Colonoscopy is generally safe, with an adverse event rate of 2.8 per 1000 procedures, but serious complications like hemorrhage and perforation are more common when polypectomy is performed.

The article emphasizes the importance of preventing and managing adverse events specifically related to polypectomy and endoscopic mucosal resection of colonic lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events related to colonic endoscopic mucosal resection and polypectomy. Sethi, A., Song, LM.[2022]

The AGREE classification system for adverse events in gastrointestinal (GI) endoscopy was validated and showed an 80% agreement in severity perception among endoscopists, nurses, and patients, indicating its reliability.

The AGREE classification correlated significantly with the established ASGE classification, and was deemed simple, reproducible, and useful by 96% of experts, suggesting it can enhance the standardization and quality assurance of AE reporting in GI endoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel classification for adverse events in GI endoscopy: the AGREE classification. Nass, KJ., Zwager, LW., van der Vlugt, M., et al.[2023]

A multimodal approach combining endoscopy and diffusion-weighted MRI (DWI-MRI) provides the most accurate assessment of response in early-stage rectal cancer after neoadjuvant chemoradiotherapy, achieving a high negative predictive value of 90.9%.

In a study involving 36 patients assessed by endoscopy and 25 patients assessed by DWI-MRI, the combination of both methods improved diagnostic accuracy significantly compared to using either method alone, indicating the importance of integrating different diagnostic tools for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopy and MRI for restaging early rectal cancer after neoadjuvant treatment. Stijns, RCH., Leijtens, J., de Graaf, E., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Predictive Value of Endoscopic Features for a Complete Response After Chemoradiotherapy for Rectal Cancer. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic evaluation of clinical response after preoperative chemoradiotherapy for lower rectal cancer: the significance of endoscopic complete response. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Adding Narrow-Band Imaging to Chromoendoscopy for the Evaluation of Tumor Response to Neoadjuvant Therapy in Rectal Cancer. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Endoscopic Feature and Response Reproducibility in Tumor Assessment after Neoadjuvant Therapy for Rectal Adenocarcinoma. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Management of complete response after chemoradiation in rectal cancer. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Association of polypectomy techniques, endoscopist volume, and facility type with colonoscopy complications. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Grading the complexity of endoscopic procedures: results of an ASGE working party. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

Clinical course and management of adverse events after endoscopic resection of superficial duodenal epithelial tumors: Multicenter retrospective study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Adverse events related to colonic endoscopic mucosal resection and polypectomy. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Novel classification for adverse events in GI endoscopy: the AGREE classification. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Endoscopy and MRI for restaging early rectal cancer after neoadjuvant treatment. [2023]